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BioWorld - Friday, December 5, 2025

IDE

Home » Topics » Regulatory » IDE
  • Symani system 28feb24
    Nov. 10, 2025
    By Holland Johnson

    MMI gets IDE for robotic microsurgical study in Alzheimer’s

    Medical Microinstruments Inc., reported the U.S. FDA approval of an investigational device exemption for a study using its Symani surgical system for treating Alzheimer’s disease, one of its earliest forays into the brain.
  • Collaboration illustration
    Nov. 4, 2025
    By Marian (YoonJee) Chu

    CG Bio, Nexgel developing long-acting drug delivery system

    Nexgel Biotech Co. Ltd. and CG Bio Co. Ltd. agreed to co-develop a thermosensitive polyphosphazene hydrogel-based long-acting drug delivery platform through a new collaboration agreement signed Oct. 31.
  • Onward arc im system 5mar25
    Aug. 19, 2025
    By Shani Alexander

    Onward Medical receives FDA IDE for BP study with ARC-IM system

    Onward Medical NV secured U.S. FDA investigational device exemption (IDE) approval for a pivotal study to assess the safety and efficacy of its implantable spinal stimulation technology, the ARC-IM system. The Empower study BP study will focus on addressing blood pressure instability in patients with spinal cord injury (SCI).
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